Role of Vitamin D in Androgenetic Alopecia

NCT ID: NCT03154528

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-30

Study Completion Date

2019-12-12

Brief Summary

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Androgenetic alopecia is a common form of diffuse hair loss in both men and women,It primarily affects the top and front of the scalp with different clinical presentations and there are numerous classification systems for grading purposes.

Detailed Description

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These systems vary from the simple systems based on recession of the hairline to more advanced multifactorial systems based on morphological and dynamic parameters that affect the scalp and hair. Most of these systems have certain limitations. Currently, the most commonly used are Hamilton- Norwood classification system for males where there are two areas of hair loss that gradually enlarge to produce recession at the temples and thinning in the crown. These regions coalesce until the entire front, top and crown (vertex) of the scalp are bald(2 major pattern,7 grades) and the Ludwig system for females which classify the Female Pattern Hair Loss into three grades depending on the reduction in hair density over the crown and frontal scalp with retention of the frontal hairline.

Etiopathogenesis of Androgenetic Alopecia has not yet been fully elucidated. Genetic factors, hair follicle cycle abnormalities, aging process and androgen dependent process including end organ sensitivity have been all incriminated as etiological factors .

Dermoscopy has emerged as an useful tool in the diagnosis of hair loss disorder including Androgenetic Alopecia. Important features of Androgenetic Alopecia on Dermoscopy include hair shaft thickness heterogeneity, yellow dots (irregularly distributed and with a remarkable variability in size and shape), perifollicular discolouration (the peripilar sign), an increased proportion of thin and vellus hairs (\>10 % of the hairs) and a large number of follicular units with only one emerging hair shaft. Thin wavy hair and honeycomb hyperpigmentation often coexist as additional, nonspecific features Vitamin D is a secosteroid hormone that plays an important role in calcium homeostasis and bone health. It has three sources: endogenous synthesis in the skin, which is induced by Ultraviolet B radiation; dietary intake; and supplementation .

Basically, Vitamin D is a modulator of both innate and adaptive immune systems through its various effects on T and B lymphocytes, dendritic cells and macrophages. There is a well-established causal connection between vitamin D deficiency and some autoimmune diseases , and possible association with some hair disorders, as it has been demonstrated that vitamin D receptors are strongly expressed in hair follicles and keratinocytes. Such an expression was found to be necessary for maintenance of the normal hair cycle. Also, it has also been shown that lack of vitamin D receptors reduces epidermal differentiation and hair follicle growth, and that an optimum concentration of Vitamin D3 is essential to delay aging and hair loss.

Several studies were done to evaluate the role of vitamin D in different hair disorders with contrasting results. Some studies revealed low serum levels of Vitamin D in women with chronic telogen effluvium,Female Pattern Hair Loss and Alopecia Areata.While, two studies showed no correlation between the extent and severity of male androgenetic alopecia with serum Vitamin D3 level.

Based on the above contrasting reports, we sought to evaluate the levels of Vitamin D in patients with androgenetic alopecia in order to establish its possible role in the etiopathogenesis and hence in the treatment of such a common and chronic hair disorder

Conditions

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Alopecia, Androgenetic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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healthy control group

serum level of Vitamin D is going to be checked by ELISA in 30 healthy control volunteers

serum vitamin D level by ELISA

Intervention Type DIAGNOSTIC_TEST

The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects

case study group

serum level of Vitamin D is going to be checked by ELISA in 60 Androgenetic Alopecia patients.

serum vitamin D level by ELISA

Intervention Type DIAGNOSTIC_TEST

The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects

Interventions

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serum vitamin D level by ELISA

The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* The study will include 60 patients with androgenetic alopecia (30 males \& 30 females) and 30 age and sex-matched healthy volunteers.

Exclusion Criteria

\- 1-Patients with a history of topical or systemic treatment within the last month.

2-Patients with a history of concomitant skin or systemic disease. 3- Pregnant or lactating women. 4- Smokers. 5- Patients receiving phototherapy within 6 months
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Miral Hassan

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miral Taya, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut Uneversity

Central Contacts

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Eman Mohamed, MD

Role: CONTACT

00201005298992

Ayman Mohamed, MD

Role: CONTACT

00201009948311

References

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Varothai S, Bergfeld WF. Androgenetic alopecia: an evidence-based treatment update. Am J Clin Dermatol. 2014 Jul;15(3):217-30. doi: 10.1007/s40257-014-0077-5.

Reference Type RESULT
PMID: 24848508 (View on PubMed)

Gupta M, Mysore V. Classifications of Patterned Hair Loss: A Review. J Cutan Aesthet Surg. 2016 Jan-Mar;9(1):3-12. doi: 10.4103/0974-2077.178536.

Reference Type RESULT
PMID: 27081243 (View on PubMed)

Vujovic A, Del Marmol V. The female pattern hair loss: review of etiopathogenesis and diagnosis. Biomed Res Int. 2014;2014:767628. doi: 10.1155/2014/767628. Epub 2014 Apr 9.

Reference Type RESULT
PMID: 24812631 (View on PubMed)

Orme S, Cullen DR, Messenger AG. Diffuse female hair loss: are androgens necessary? Br J Dermatol. 1999 Sep;141(3):521-3. doi: 10.1046/j.1365-2133.1999.03049.x.

Reference Type RESULT
PMID: 10583059 (View on PubMed)

Kaliyadan F, Nambiar A, Vijayaraghavan S. Androgenetic alopecia: an update. Indian J Dermatol Venereol Leprol. 2013 Sep-Oct;79(5):613-25. doi: 10.4103/0378-6323.116730.

Reference Type RESULT
PMID: 23974579 (View on PubMed)

Errichetti E, Stinco G. Dermoscopy in General Dermatology: A Practical Overview. Dermatol Ther (Heidelb). 2016 Dec;6(4):471-507. doi: 10.1007/s13555-016-0141-6. Epub 2016 Sep 9.

Reference Type RESULT
PMID: 27613297 (View on PubMed)

Bikle DD. Vitamin D metabolism and function in the skin. Mol Cell Endocrinol. 2011 Dec 5;347(1-2):80-9. doi: 10.1016/j.mce.2011.05.017. Epub 2011 Jun 1.

Reference Type RESULT
PMID: 21664236 (View on PubMed)

Arnson Y, Amital H, Shoenfeld Y. Vitamin D and autoimmunity: new aetiological and therapeutic considerations. Ann Rheum Dis. 2007 Sep;66(9):1137-42. doi: 10.1136/ard.2007.069831. Epub 2007 Jun 8.

Reference Type RESULT
PMID: 17557889 (View on PubMed)

Malloy PJ, Feldman D. The role of vitamin D receptor mutations in the development of alopecia. Mol Cell Endocrinol. 2011 Dec 5;347(1-2):90-6. doi: 10.1016/j.mce.2011.05.045. Epub 2011 Jun 13.

Reference Type RESULT
PMID: 21693169 (View on PubMed)

Amor KT, Rashid RM, Mirmirani P. Does D matter? The role of vitamin D in hair disorders and hair follicle cycling. Dermatol Online J. 2010 Feb 15;16(2):3.

Reference Type RESULT
PMID: 20178699 (View on PubMed)

Rasheed H, Mahgoub D, Hegazy R, El-Komy M, Abdel Hay R, Hamid MA, Hamdy E. Serum ferritin and vitamin d in female hair loss: do they play a role? Skin Pharmacol Physiol. 2013;26(2):101-7. doi: 10.1159/000346698. Epub 2013 Feb 20.

Reference Type RESULT
PMID: 23428658 (View on PubMed)

Banihashemi M, Nahidi Y, Meibodi NT, Jarahi L, Dolatkhah M. Serum Vitamin D3 Level in Patients with Female Pattern Hair Loss. Int J Trichology. 2016 Jul-Sep;8(3):116-20. doi: 10.4103/0974-7753.188965.

Reference Type RESULT
PMID: 27625563 (View on PubMed)

Bakry OA, El Farargy SM, El Shafiee MK, Soliman A. Serum Vitamin D in patients with alopecia areata. Indian Dermatol Online J. 2016 Sep-Oct;7(5):371-377. doi: 10.4103/2229-5178.190504.

Reference Type RESULT
PMID: 27730032 (View on PubMed)

Bolland MJ, Ames RW, Grey AB, Horne AM, Mason BH, Gamble GD, Reid IR. Does degree of baldness influence vitamin D status? Med J Aust. 2008 Dec 1-15;189(11-12):674-5. doi: 10.5694/j.1326-5377.2008.tb02241.x.

Reference Type RESULT
PMID: 19061473 (View on PubMed)

Other Identifiers

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MAGA2017

Identifier Type: -

Identifier Source: org_study_id

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